The Department of Health and Human Services (HHS) is proposing changes to modernize regulations that interpret the physician self-referral law, also known as the Stark law, and the federal anti-kickback statute. A special exemption for certain clinical laboratory and anatomic pathology testing in the Stark law has long been a cause for concern in the laboratory medicine community, as many believe it incentivizes inappropriate physician self-referral and overutilization in anatomic pathology. Many tests and procedures fall under this exemption so that they may be performed in a physician’s office to guide diagnosis and treatment. The proposed changes, however, do not close the anatomic pathology exemption.

Instead, the rules focus on clearing obstacles for providers who participate in value-based payment plans through Medicare and provide coordinated care for patients. The proposals would ease the compliance burden for providers while maintaining strong safeguards to protect patients and programs from fraud and abuse, according to HHS.

The proposed rules are part of a larger agency effort to promote value-based care by examining regulations that may keep providers from offering highly coordinated care. The goal is to acknowledge that incentives—both good and bad—are different in a healthcare system that pays for value, rather than the volume, of services provided.

As an illustration of such coordinated care under the new rules, HHS offered the example of a provider giving patients technology that is capable of monitoring their health and enabling two-way, real-time interactive communication between the patient, facility, and physician. In such a scenario, the facility also could equip the physicians with data analytics software to help them monitor patient health outcomes, HHS noted.

Grants, Planning Launch New HIV Prevention Effort

As part of a new federal initiative focused on ending the HIV epidemic and reducing new HIV infections in America by 90% by 2030, the Centers for Disease Control and Prevention (CDC) has awarded $13.5 million to conduct state and local planning and kick off community involvement for the plan.

Some $12 million will go to 32 CDC-funded state and local health departments to develop comprehensive plans tailored for each community. Plans will be based upon a national government framework that identified the highest-impact HIV prevention, care, treatment, and outbreak response strategies.

The rest of the funds will go to the National Alliance of State and Territorial AIDS Directors (NASTAD) to enhance local health departments’ capacity. This effort will use CDC HIV prevention funds to support strategic communication and policy activities, partnerships, data analyses, and technical assistance.

The Department of Health and Human Services (HHS) is emphasizing its community outreach in the administration’s HIV program. HHS agencies have sought input from leaders at national conferences, webinars, meetings with national organizations, and site visits, according to the agency.

“Our goal is to ensure that the key pillars of HIV prevention and treatment are delivered in a manner planned by the community, in the community, and for the community,” said CDC Director Robert R. Redfield, MD.

Executive Order Opens New Questions on Medicare Policy

A presidential executive order on Medicare will task the government’s healthcare bureaucracy with developing a suite of new proposals, regulations, and research projects that could reshape how many Americans receive care.

The executive order emphasizes some approaches—such as value-based payment policy—that already are in the works. Others, while yet to be fleshed out by agency action, also are aimed at reducing costs and could reignite debates about the structure of the program.

For example, the order requires the government to study how to more closely align government healthcare payment with private, market-based rates; allow patients to negotiate contracts directly with providers; expand high-deductible Medicare plans that include funded savings accounts for patients to pay for care; and encourage more equal payment for care provided by nurse practitioners and other non-physician practitioners.

Most of the policy outlined in the order gives the Secretary of the Department of Health and Human Services 1 year to develop proposals to implement each plan.